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Evaluation of ACCS100 to Reduce Aflatoxin Exposure in Kenya

NCT02188953 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-09-16

No results posted yet for this study

Summary

The purpose of this study is to pilot test the effectiveness, acceptability, and palatability of ACCS100 in a high-risk Kenyan population.

Conditions

  • Aflatoxicosis

Interventions

DRUG

ACCS100

ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.

DRUG

Calcium carbonate placebo

Sponsors & Collaborators

Principal Investigators

  • John Vulule, PhD · Kenya Medical Research Institute

  • Ellen Yard, PhD · U.S. Centers for Disease Control and Prevention

  • Johnni Daniel, MPH · U.S. Centers for Disease Control and Prevention

  • Timothy Philips, PhD · Texas A&M University

  • Samuel Amwayi, MD · Kenya Ministry of Public Health and Sanitation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Kenya

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02188953 on ClinicalTrials.gov